Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non Alcoholic Steatohepatitis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate the efficacy and safety of berberine on subjects with Non-alcoholic Steatohepatitis.Patients with biopsy-proven non-alcoholic steatohepatitis (NASH) from 18-65 years of age were enrolled. Patients sho...
This is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate the efficacy and safety of berberine on subjects with Non-alcoholic Steatohepatitis.Patients with biopsy-proven non-alcoholic steatohepatitis (NASH) from 18-65 years of age were enrolled. Patients should had no excessive alcohol intake or use of any hepatoprotective or hepatotoxicity medication within 3 months before enrollment.Patients will have an screening period 12 weeks, and a 48-week double-blinded treatment period.
Tracking Information
- NCT #
- NCT03198572
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- The Affiliated Hospital of Hangzhou Normal University
- Tianjin Third Central Hospital
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Xinjiang Medical University
- Investigators
- Principal Investigator: Xin Gao Fudan University
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